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In similar drug approach, the existing pharmacokinetics data for another drug of the same pharmacological category may be used. Here, the dose selection is based on minimum risk of toxicity, instead of choosing one with minimum pharmacologic activity in humans.
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The dose by factor method is an empirical approach and use the no observed adverse effect levels (NOAEL) of drug from preclinical toxicological studies to estimate human equivalent dose (HED). There are four different methods namely dose by factor, similar drug, pharmacokinetically guided, and comparative approaches are described in literature to assess the initial dose.
#List of i doser doses and descriptions trial#
Therefore, extrapolation of dose from animals to humans needs consideration of body surface area, pharmacokinetics, and physiological time to increase clinical trial safety. This is primarily because the biochemical, functional systems in species vary which in turn alter pharmacokinetics. It should be emphasized that the common perception of scaling of dose based on the body weight (mg/kg) alone is not the right approach. Therefore, choosing starting dose of such drugs for research, experiments, or clinical trials in animals and humans is a concern. There are several instances, wherein the initial dose of a particular drug is unavailable in a specific species. Safe and effective drug dosing is necessary, regardless of its purpose of administration.